RESPONSIBILITIES:Kforce's client, a growing and fast paced medical device company in Phoenix, Arizona (AZ) is looking for a Senior Product QA Engineer. They are looking for candidates nationwide willing to relocate to Arizona.
In this role, you will provide Manufacturing Quality Assurance. Success in this commitment would be the implementation of a self-sustaining, divisional manufacturing support quality organization aligned with and supporting Business and Quality System processes.
- Creating and communicating expectations of team members
- Identifying capability gaps for QA associates and ensuring appropriate resources to support product line teams
- Developing QA associates and creating an environment that engages associates and drives results
- Providing Subject Matter Expertise to the Manufacturing QA organization as it relates to combination products
- Collaborating with other Product Operations Quality Leaders, Quality Operations and the QA Compliance team to implement best practices in alignment with requirements
- Participating in external audits related to the product lines/plants; This may include, speaking to the auditors about FIRs, execution of the quality system, and exhibiting familiarity and understanding of the product as it pertains to the Quality System
- Providing technical direction, Subject Matter Expertise, for quality process improvement to ensure successful implementation within the Manufacturing QA organization
- Being accountable for resolution of waterline issues related to quality in collaboration with review boards
- Bachelor's degree
- At least 5-8 years of experience in the medical device or pharmaceutical industries with a record of increasing responsibilities
- At least 5 years of Quality Assurance related experience supporting combination product medical devices or in the pharmaceutical industry
- At least 4 years of demonstrated track record of success in a leadership role
- Experience as a primary liaison for FDA and Notified Body inspections/audits
- Successful track record of leading through influencing as well as developing individuals and teams required
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.